Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment. [ Time Frame: 5 to 21 days after the last dose of study therapy, or at early termination. ] [ Designated as safety issue: No ]

The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.

Original Primary Outcome Measures ICMJE (submitted: July 16, 2007)

Clinical response will be assessed 7 to 14 days after the end of therapy. Serious bacteria burden will be tracked and correlated with clinical response.

Clinical Response Rates at the Late Follow-up Assessment. [ Time Frame: 28 to 35 days after last dose of study therapy ] [ Designated as safety issue: No ]

The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.

Original Secondary Outcome Measures ICMJE (submitted: July 16, 2007)

Long-term clinical response will be assessed 28 to 35 days after the end of therapy.Microbiologic response 7 to 14 days after the end of therapy. Microbiologic evaluation for relapse 28 to 35 days after the end of therapy.

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia

Official Title ICMJE

A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

Detailed Description

Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.